FDA.reportPublic FDA data

Forward

Primary DI
00860000925310
Brand
Forward
Company
Synchronis Medical, LLC
Model
4818-60002
Catalog number
4818-60002
Device description
Field Recipient Blood Transfusion Kit
Published
2021-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
POQBlood Transfusion Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POQBlood Transfusion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015884009PackageGS112In Commercial Distribution
00860000925310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015884009008500158840098500158840090850015884009
00860000925310008600009253108600009253100860000925310

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfusion set, non-exchangeAn intravascular administration set intended to be used to administer blood from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device typically includes a needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, a stopcock, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an intravenous (IV) bag or other infusion fluid container. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-752-1011info@integratedmc.com

Regulatory Flags#

DUNS number
080160207
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850015884641easycare3200-100003200-100002026-02-20
00850015884757easycare3200-100023200-100022026-02-20
00850015884955easycare3200-100103200-100102026-02-20
00850015884979easycare3200-100123200-100122026-02-20
00850015884993easycare3200-100143200-100142026-02-20
00850063404013easycare3200-100163200-100162026-02-20
00850063404037easycare3200-100203200-100202026-02-20
00850015884658easycare3200-100003200-100002026-02-20
00850015884764easycare3200-100023200-100022026-02-20
00850015884962easycare3200-100103200-100102026-02-20
00850015884986easycare3200-100123200-100122026-02-20
00850063404006easycare3200-100143200-100142026-02-20
00850063404020easycare3200-100163200-100162026-02-20
00850063404044easycare3200-100203200-100202026-02-20
00860000925303easycare3200-100383200-100382026-02-20
00850063404051easycare3200-100223200-100222026-02-13
00850063404075easycare3200-100243200-100242026-02-13
00850063404099easycare3200-100263200-100262026-02-13
00850063404112easycare3200-100303200-100302026-02-13
00850063404136easycare3200-100323200-100322026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M68980820120Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2026-01-22
M68980821110Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2026-01-22
M68980801060Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2025-05-05
M68980821100Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2024-12-27
M68980820110Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2024-12-16
00850062467019Project Lavoy Blood KitAltitude Technologies Inc.POQ2024-06-19
00856767008045Training TMM-FBT-LTA (Tactical Medical Module-Field Blood Transfusion -Low TiterAltitude Technologies Inc.POQ2024-01-18
00842209128129NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00842209128198NARNORTH AMERICAN RESCUE, LLCPOQ2023-08-10
00810094575823CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575830CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575878CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
00810094575885CuraplexBOUND TREE MEDICAL, LLCPOQ2023-04-30
M68980820070Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-11-04
M68980821070Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-11-04
M68980801040Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-10-05
00842209124619NARNORTH AMERICAN RESCUE, LLCPOQ2022-08-31
M68980820060Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2022-08-22
M68980821060Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2022-08-22
M68980801050Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2022-08-09
M68980821050Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-10-02
M68980820050Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-10-02
M68980801030Fresh Whole Blood Transfusion SetSafeguard US Operating, LLCPOQ2021-10-01
00860000925372ForwardSynchronis Medical, LLCPOQ2021-09-17
00850015884009ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
00850015884061ForwardSYNCHRONIS MEDICAL, LLCPOQ2021-09-17
M68980820040Valkyrie LTOWB Collection SetSafeguard US Operating, LLCPOQ2021-07-19
M68980821040Valkyrie LTOWB Administration SetSafeguard US Operating, LLCPOQ2021-07-19
00812277037142CuraplexBOUND TREE MEDICAL, LLCPOQ2021-02-28
00842209118182NARNORTH AMERICAN RESCUE, LLCPOQ2021-02-08